Heated chemo wash during surgery aims to stop gallbladder cancer spread
NCT ID NCT05430035
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving heated chemotherapy directly into the abdomen during surgery is safe for people with high-risk gallbladder cancer. The treatment aims to prevent cancer from coming back in the belly lining. Ten participants will be enrolled to check for complications and recovery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed gallbladder adenocarcinoma AND inadvertent spillage of bile or intentional decompression during cholecystectomy OR tumors extending through the serosa of the gallbladder (T3/T4) OR poorly differentiated gallbladder adenocarcinoma. * ECOG Performance status ≤ 2 * Subjects must have normal organ and marrow function as defined below: * Hemoglobin ≥ 10.0 g/dl * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcL * Platelet count ≥ 100,000/mcL * Total bilirubin within normal institutional limits * AST (SGOT) ≤ 2.5 X institutional upper limit of normal * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal * Serum Creatinine within normal institutional limits * Eligible TNM staging includes \>T1b meeting above criteria, any N, and M0 * Eligible candidates for standard surgical management which includes central liver resection (+ cholecystectomy if not already performed) and portal lymphadenectomy * Subjects must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Prior systemic therapy for gallbladder adenocarcinoma * Subjects receiving any other investigational agents. * Subjects with known or suspected metastatic disease * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MMC or other agents used in this study. * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breastfeeding are excluded from this study because MMC has the potential for teratogenic or abortifacient effects. Because there is known risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breastfeeding should be discontinued if the mother is treated with MMC. * Subjects with past medical history of hepatitis B or C * Subjects with evidence of biliary obstruction thought to be cancer related, including subjects requiring biliary stent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West Virginia University Cancer Institute Mary Babb Randolph Cancer Center
RECRUITINGMorgantown, West Virginia, 26506, United States
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Other studies related to the condition(s) this trial covers.
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